Ambulatory Stroke Unit Treatment for Elderly Patients (ARTIFICE)

Ambulatory Stroke Unit Treatment for Elderly Patients: A Prospective, Randomized, Controlled, Exploratory Non-Inferiority Trial (ARTIFICE)

ARTIFICE is a prospective, multicenter, randomized, controlled, exploratory non-inferiority trial evaluating whether an ambulatory stroke unit model (aSU) is non-inferior to conventional inpatient stroke unit care (SU) in patients aged 60 years or older with acute ischemic stroke, transient ischemic attack (TIA), or retinal ischemia and non-disabling neurological deficits.

Eligible patients are randomized 1:1 to same-day comprehensive ambulatory multiprofessional stroke evaluation (aSU) or guideline-based inpatient stroke unit treatment (SU). The primary endpoint is favorable functional outcome at 90 days, defined as modified Rankin Scale (mRS) 0-2 or return to pre-stroke mRS. Endpoint assessment at 90 days is performed by blinded assessors (PROBE design).

Secondary outcomes include early neurological deterioration, recurrent stroke, delirium, mortality, health-related quality of life, healthcare utilization, and cost-effectiveness. A mixed-methods process evaluation examines feasibility, acceptability, and implementation aspects of the ambulatory care model.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke; Retinal Ischemia; Transient Ischemic Attack (TIA)
• Intervention / Treatment: Other: Ambulatory Stroke Unit Care; Other: Conventional Stroke Unit Care

Detailed Description

Stroke unit treatment in Germany is currently organized as multi-day inpatient care regardless of stroke severity. However, a substantial proportion of patients with acute ischemic stroke or transient ischemic attack present with non-disabling or fully regressed neurological deficits and may not require prolonged inpatient monitoring. At the same time, demographic changes and increasing stroke incidence in older populations challenge inpatient stroke unit capacity and resource allocation.

International experience with structured outpatient TIA and minor stroke clinics suggests that ambulatory management models may provide comparable clinical safety while reducing hospital utilization. However, randomized evidence for such models within the German healthcare system is lacking.

The ARTIFICE trial evaluates a structured ambulatory stroke unit care model designed to provide comprehensive same-day multiprofessional assessment and initiation of secondary prevention while maintaining patient safety. The study investigates whether this ambulatory care approach can represent a medically safe and resource-efficient alternative to conventional inpatient stroke unit treatment in selected older patients.

In addition to clinical effectiveness, the study examines patient-reported outcomes, healthcare utilization, cost-effectiveness, and implementation aspects to inform future health services planning.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jan C Purrucker, Prof. Dr.; Phone Number: +49 6221 56 6999; Email: artifice.studie@med.uni-heidelberg.de

Study Locations

• Germany
  • Heidelberg, Germany, 69120
    • Recruiting
    • Heidelberg University Hospital
    • Contact: Dorit Arlt, Dr.; Phone Number: +49 6221 56 6999; Email: neurologie@med.uni-heidelberg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 60 years
• Diagnosis of acute ischemic stroke (ICD-10 I63.), transient ischemic attack (G45.), or retinal ischemia (H34.*)
• Symptom onset ≤ 7 days before enrollment
• No or non-disabling newly occurring neurological deficit allowing safe ambulatory management
• Written informed consent provided by the participant or, if lacking decision-making capacity, by a legally authorized representative

Exclusion Criteria:

• Requirement for urgent surgical or interventional secondary prevention (e.g., carotid revascularization)
• Fluctuating stroke symptoms within the previous 48 hours
• Acute febrile infection or isolation-requiring infectious disease
• Clinically relevant dysphagia with high aspiration risk
• Critical medical or nursing findings requiring mandatory multi-day inpatient treatment
• Palliative care situation with limitation of acute diagnostic or therapeutic measures
• Previous participation in the ambulatory stroke unit care model
• No statutory health insurance coverage in Germany
• Insufficient German language proficiency to understand study procedures and assessments

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ambulatory Stroke Unit Care (aSU); Participants receive structured ambulatory stroke unit care consisting of comprehensive same-day multiprofessional assessment, diagnostic evaluation, and initiation of secondary prevention. After evaluation, clinically stable participants are discharged home with structured follow-up.	Other: Ambulatory Stroke Unit Care; Structured ambulatory stroke care model providing same-day neurological assessment, diagnostic work-up, therapeutic evaluation, and multidisciplinary case review, followed by discharge home if medically appropriate.
Active Comparator: Inpatient Stroke Unit Care (SU); Participants receive guideline-based inpatient stroke unit treatment according to standard clinical practice, including monitoring and diagnostic evaluation during hospital admission.	Other: Conventional Stroke Unit Care; Standard inpatient stroke unit treatment according to national clinical guidelines, including hospital-based monitoring, diagnostic evaluation, and initiation of secondary prevention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Favorable Functional Outcome at 90 Days	Favorable functional outcome defined as modified Rankin Scale (mRS) score 0-2 or return to pre-stroke mRS level, assessed by blinded outcome assessors.	90 days (±14 days) after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early Neurological Deterioration	Increase in National Institutes of Health Stroke Scale (NIHSS) score of ≥4 points compared to baseline.	Within 7 days after randomization
Recurrent Stroke	Occurrence of recurrent ischemic stroke, hemorrhagic stroke, or transient ischemic attack during follow-up.	Up to 90 days after randomization (primary safety observation period)
Delirium Occurrence	Occurrence of delirium assessed using the Confusion Assessment Method (CAM).	Within 7 days after randomization
All-Cause Mortality	Death from any cause.	90 days and 12 months after randomization
Functional Status	Change in Barthel Index score from baseline to 90 days.	Baseline and 90 days
Stroke Impact	Change in SIS-16 score from baseline to 90 days.	Baseline and 90 days
Mobility	Change in Timed Up and Go Test (TUG) time from baseline to 90 days.	Baseline and 90 days
Health-Related Quality of Life	Change in EQ-5D-5L index value and EQ visual analogue scale (EQ-VAS) from baseline to 90 days.	Baseline and 90 days
Healthcare Utilization	Use of outpatient, inpatient, and nursing care services assessed by questionnaire.	Up to 90 days after randomization
Serious Adverse Events	Occurrence of serious adverse events including unplanned hospitalization or death.	Up to 90 days after randomization

Collaborators and Investigators

• Sponsor: University Hospital Heidelberg
• Collaborators: Heidelberg University Hospital - Coordination Centre for Clinical Trials (KKS); inav - Institute for Applied Health Services Research GmbH, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Quality of Life; Health Services Research; Modified Rankin Scale; Delirium; Transient Ischemic Attack; Cost-Effectiveness; Minor Stroke; Non-Inferiority Trial; Ambulatory Stroke Unit; Stroke Unit Care; Geriatric Stroke; Care Delivery Model; Integrated Stroke Care; Post-Stroke Outcome; Stroke Recurrence
• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Brain Ischemia; Stroke; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Ischemic Stroke; Delirium; Ischemic Attack, Transient
• Other Study ID Numbers: S-689/2025 (ARTIFICE); 01NVF24306 (Other Grant/Funding Number: Federal Joint Committee (G-BA), Germany)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be made publicly available. De-identified data may be shared with qualified researchers upon reasonable request, subject to approval by the sponsor and in accordance with applicable data protection regulations (including GDPR), institutional policies, and a data use agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No